Assignments to the Operational Teams (and a few editorial comments)

GOAL OF PHIDISA: To develop a state-of-the-art clinical research program within the SANDF that will address scientifically valid research questions of importance and relevance to SANDF with an initial focus on HIV disease

Four Key Elements of a Successful Research Program n Strong scientific agenda n Strong operational platform n Transparent processes and procedures n Simple, Flexible, Fun Prof. Jim Neaton University of Minnesota n Strong scientific agenda n Strong operational platform n Transparent processes and procedures n Simple, Flexible, Fun Prof. Jim Neaton University of Minnesota

Specific Goals for the Next 12 Months n Establishment of all 6 sites n Approval of Phidisa 3 n Implementation of all 3 protocols at all 6 sites n Development of a more robust training program with opportunities for Phidisa members to obtain advanced degrees n Abstract presentations at international meetings n Establishment of all 6 sites n Approval of Phidisa 3 n Implementation of all 3 protocols at all 6 sites n Development of a more robust training program with opportunities for Phidisa members to obtain advanced degrees n Abstract presentations at international meetings

Structure of Teams for the Conference n Executive Committee (MG Radebe, BG Motumi, Dr. Brodine, Dr. Lane) n External Advisory Committee (Dr. Mbele, Dr. Webber, Capt. Martin) n Operational Teams n Data and IT (Maj. Mthetwa and Dr. Neaton) n Protocol (Col. Naidoo and Dr. Emery) n Executive Committee (MG Radebe, BG Motumi, Dr. Brodine, Dr. Lane) n External Advisory Committee (Dr. Mbele, Dr. Webber, Capt. Martin) n Operational Teams n Data and IT (Maj. Mthetwa and Dr. Neaton) n Protocol (Col. Naidoo and Dr. Emery)

Teams for the Conference (2) n Operational Teams (con’t.) n Pharmacy (Ms. Matchaba and Dr. Pau) n Regulatory and Ethics (Col. Currie and Ms. Mcnay) n Economics (R Adm Engelbrecht and Dr. Rosen) n Laboratory (Dr. Makatini and Dr. Dewar) n Operational Teams (con’t.) n Pharmacy (Ms. Matchaba and Dr. Pau) n Regulatory and Ethics (Col. Currie and Ms. Mcnay) n Economics (R Adm Engelbrecht and Dr. Rosen) n Laboratory (Dr. Makatini and Dr. Dewar)

Teams for the Conference (3) n Operational Teams (con’t.) n Training (Capt. Motaung and Ms. Zuckerman) n Communications (Lt. Senokwanyane and Ms. Doepel) n Site management / Clinical Care (Col. Ratsela and Dr. Masur) n Operational Teams (con’t.) n Training (Capt. Motaung and Ms. Zuckerman) n Communications (Lt. Senokwanyane and Ms. Doepel) n Site management / Clinical Care (Col. Ratsela and Dr. Masur)

Executive Committee (EC) MG M. Radebe, BG N. Motumi, Dr. S. Brodine, Dr. C. Lane Operational Teams DMCOC Sections Pharmacy Section Head: Ms. U. Matchaba U.S. Partner: Dr. A. Pau U.S. Partner: A. Prof. S. Emery Protocol Section Head : Col C. Naidoo Economics Team Leader: RAdm.G Engelbrecht Clinical Care Team Leader: Col. A. Ratsela Laboratory Section Head : Dr. Z. Makatini Data Management Section Head : Maj. J. Mthetwa Training Section Head : Capt. J. Motaung Communications Section Head: Lt. S. Senokwanyane Regulatory/Ethics Section Head : Col. X. Currie U.S. Partner: Dr. H. Masur U.S. Partner: Ms. J. Zuckerman U.S. Co-Chair: Ms. L. McNay U.S. Partner: Ast. Prof. S Rosen U.S. Partner: Ms. L. McNay U.S. Partner: Prof. J. Neaton U.S. Partner: Dr. R. Dewar Data Management and Operations Center (DMCOC) Col Msimang, Dorector Dr. Dhlomo, Deputy Director S.A. – U.S. PHIDISA PROJECT “Make Better, Prolong Lives” ORGANIZATIONAL STRUCTURE IRB IRB Chair Prof O Mzileni External Advisory Committee Advisory Chair Dr. N Mbelle Site Developmpment Dr. J Osterman

Tasks for All Operational Teams (1) n Report accomplishments over the past year n Develop goals for the upcoming year n Identify resources (including annual budget) required to meet those goals n Report accomplishments over the past year n Develop goals for the upcoming year n Identify resources (including annual budget) required to meet those goals

Tasks for All Operational Teams (2) n Review current composition of team and recommend changes n Review and approve or recommend changes to relevant PDs (Dr. Tavel). n Submit report to EC by Thursday evening n Review current composition of team and recommend changes n Review and approve or recommend changes to relevant PDs (Dr. Tavel). n Submit report to EC by Thursday evening

Specific Issues for Protocol (03) Process for final approval: n 2 weeks - working groups get comments to protocol via chair/ co-chair. (copy to EC) n 4 weeks - protocol gets “final” version to EC for approval along with comments they had received. n 5 weeks - approved protocol to NIAID IRB. Process for final approval: n 2 weeks - working groups get comments to protocol via chair/ co-chair. (copy to EC) n 4 weeks - protocol gets “final” version to EC for approval along with comments they had received. n 5 weeks - approved protocol to NIAID IRB.

Specific Issues for Protocol (04) § Consider protocol amendments (if any) for Phidisa 1 and Phidisa 2 (?avoid nevirapine in pregnant women) - involve clinical care / site development; data; lab. § Obtain consensus on Phidisa 3 including definition of nutritional intervention § Consider protocol amendments (if any) for Phidisa 1 and Phidisa 2 (?avoid nevirapine in pregnant women) - involve clinical care / site development; data; lab. § Obtain consensus on Phidisa 3 including definition of nutritional intervention

Specific Issues for Data (03) n Renamed Data Management and Operations n Develop a strategy for protocol governance (concept to completion); site establishment. n Charged with establishment of an operations center n At 1 military if able to be done immediately n In rental space as an interim measure if not n Renamed Data Management and Operations n Develop a strategy for protocol governance (concept to completion); site establishment. n Charged with establishment of an operations center n At 1 military if able to be done immediately n In rental space as an interim measure if not

Specific Issues for Data and IT (04-1) n Determine reports for DSMB n Develop procedures for responding to data edit queries n Determine procedures for responding to data requests n Develop strategy for maintenance of Manual of Operations (MOOPs), forms, FAQs n Determine reports for DSMB n Develop procedures for responding to data edit queries n Determine procedures for responding to data requests n Develop strategy for maintenance of Manual of Operations (MOOPs), forms, FAQs

Specific Issues for Data and IT (04-2) n Work with communications to develop web- based reports n Recommend strategies for improved telecommunications (esp. internet) n Review progress on access to US National Library of Medicine n Work with communications to develop web- based reports n Recommend strategies for improved telecommunications (esp. internet) n Review progress on access to US National Library of Medicine

Specific Issues for Multidisciplinary Site Development (03) n Develop initial, feasible staffing plans for January; June; December, Begin with 1 Mil and Mtubatuba. n Develop strategy for hiring staff (SANDF; contract; other); governance of sites. n Develop list of equipment / supply needs. n Submit plan by September 1. n Develop initial, feasible staffing plans for January; June; December, Begin with 1 Mil and Mtubatuba. n Develop strategy for hiring staff (SANDF; contract; other); governance of sites. n Develop list of equipment / supply needs. n Submit plan by September 1.

Specific Issues for Multidisciplinary Site Development/ Clinical Care (04-1) n Review staffing, PDs, MOOPs, governance and SOPs at 1 Mil and Mtubatuba (with data, lab regulatory) - recommend any changes; review role of US staff n Project enrollment at 1Mil, Mtubatuba, Capetown (to open in September) and Umtata (to open in October) over the next year. n Work with protocol to consider amendments to Phidisa 1 and 2 and to complete Phidisa 3 n Review staffing, PDs, MOOPs, governance and SOPs at 1 Mil and Mtubatuba (with data, lab regulatory) - recommend any changes; review role of US staff n Project enrollment at 1Mil, Mtubatuba, Capetown (to open in September) and Umtata (to open in October) over the next year. n Work with protocol to consider amendments to Phidisa 1 and 2 and to complete Phidisa 3

Specific Issues for Multidisciplinary Site Development/ Clinical Care (04-2) n Review pediatric SOPs n Project need for PEPFAR drugs (pharmacy) n Develop strategies to improve communication across sites (consider separate meeting of clinical staff), between sites and DMCOC and between sites and patients (including recruitment strategies) n Coordinate above efforts with communication team n Review pediatric SOPs n Project need for PEPFAR drugs (pharmacy) n Develop strategies to improve communication across sites (consider separate meeting of clinical staff), between sites and DMCOC and between sites and patients (including recruitment strategies) n Coordinate above efforts with communication team

Specific Issues for Laboratory (03) n Initiate contracts for CD4; HIV RNA; repository and sample transport. n Develop strategy for obtaining routine safety labs. n Initiate SOPS for rapid test at point of care. n Pursue development of 1 Military lab. n Initiate contracts for CD4; HIV RNA; repository and sample transport. n Develop strategy for obtaining routine safety labs. n Initiate SOPS for rapid test at point of care. n Pursue development of 1 Military lab.

Specific Issues for Laboratory (04) n Evaluate composition of SANDF laboratory team (discuss with EC). n Develop transition strategy for funding Lancet contract as soon as possible. n Re-evaluate opportunity for development of enhanced laboratory capability within SAMHS - beginning with sample repository. n Evaluate composition of SANDF laboratory team (discuss with EC). n Develop transition strategy for funding Lancet contract as soon as possible. n Re-evaluate opportunity for development of enhanced laboratory capability within SAMHS - beginning with sample repository.

Specific Issues for Pharmaceutical Care (03) n Work with Data/Ops to develop PD; identify pharmacist for coordinating center n Work with Site Development to generate PDs; identify staff / equipment for the sites. n Approach local vendors regarding best drug prices - complete in 1 week. n Work with Data/Ops to develop PD; identify pharmacist for coordinating center n Work with Site Development to generate PDs; identify staff / equipment for the sites. n Approach local vendors regarding best drug prices - complete in 1 week.

Specific Issues for Pharmaceutical Care (04) n Project drug needs over the next year (work with site/clinical group) for Phidisa and PEPFAR. Assume 1/05 as start date for P3. n Review (with regulatory and EC) different procurement strategies for ARVs (NIH direct purchase; NIH contract purchase - using NIH funds (treatment per protocol) vs PEPFAR funds (standard of care treatment outside protocol) n Develop strategies to track ARVS that will distinguish PEPFAR from NIH funded drugs and insure uninterrupted supplies of both n Project drug needs over the next year (work with site/clinical group) for Phidisa and PEPFAR. Assume 1/05 as start date for P3. n Review (with regulatory and EC) different procurement strategies for ARVs (NIH direct purchase; NIH contract purchase - using NIH funds (treatment per protocol) vs PEPFAR funds (standard of care treatment outside protocol) n Develop strategies to track ARVS that will distinguish PEPFAR from NIH funded drugs and insure uninterrupted supplies of both

Specific Issues for Public Health (03) Specific Issues for Public Health (03) n Develop analysis plan that will utilize data from Phidisa I and II for inclusion to the body of the protocol. n Delineate data desired from other record systems and pathway for approvals to use those data. n Develop analysis plan that will utilize data from Phidisa I and II for inclusion to the body of the protocol. n Delineate data desired from other record systems and pathway for approvals to use those data.

Specific Issues for Economics (04) n Provide a detailed analysis plan for assessing the cost-effectiveness of implementing antiretroviral therapy in the SANDF

Specific Issues for Ethics (03) n Pre-IRB ethics review of protocols and generation of informed consents - 2 weeks. n Advise on best strategy for meeting requirement of indemnification. n Review composition of working group. n Informed consent trial in the future. n Pre-IRB ethics review of protocols and generation of informed consents - 2 weeks. n Advise on best strategy for meeting requirement of indemnification. n Review composition of working group. n Informed consent trial in the future.

Specific Issues for Regulatory (03) n Establish IRB; utilize subcommittee of IRB for periodic Data and Safety reviews. n Delineate regulatory pathway in RSA and expected timelines (MCC registration) n Work with Data/Ops for personnel needs n Develop SOW for CRO contract n Establish IRB; utilize subcommittee of IRB for periodic Data and Safety reviews. n Delineate regulatory pathway in RSA and expected timelines (MCC registration) n Work with Data/Ops for personnel needs n Develop SOW for CRO contract

Specific Issues for Regulatory and Ethics (04) n Review policies and suggest changes / areas in need of additional policies. Review SOP for document control. n Advise on timeline for first data and safety review. § Finalize agreement language n Review policies and suggest changes / areas in need of additional policies. Review SOP for document control. n Advise on timeline for first data and safety review. § Finalize agreement language

Specific Issues for Training (03) n Consider focused training for 1 Mil and Mtubatuba staff as soon as they are in place at the operations center and in the clinics. n Establish a program to encourage individuals to get advanced training n Re-evaluate membership n Consider focused training for 1 Mil and Mtubatuba staff as soon as they are in place at the operations center and in the clinics. n Establish a program to encourage individuals to get advanced training n Re-evaluate membership

Specific Issues for Training (04-1) n Develop immediate and long-term strategies for needs assessment and targeted training (all groups). n Determine schedule and composition of teams to come to NIH for 2-week focused training; establish criteria for selecting individuals for training. n Develop an orientation program for new hires (in person and website) - work with communications. n Develop immediate and long-term strategies for needs assessment and targeted training (all groups). n Determine schedule and composition of teams to come to NIH for 2-week focused training; establish criteria for selecting individuals for training. n Develop an orientation program for new hires (in person and website) - work with communications.

Specific Issues for Training (04-2) n Develop a mentorship program with clear guidelines - Identify key Phidisa personnel and identify a mentor for as many as possible (all operational teams) n Begin to develop the Phidisa Scholars Program (Discuss with Drs. Brodine, Emery and Neaton) - an opportunity for members of Phidisa to obtain advanced training and degrees (selection criteria / committee, pay-back obligation) n Recommend a process to identify conferences of relevance to Phidisa and to select individuals to attend those conferences (accepted abstract). Develop a budget for conference travel. n Develop a mentorship program with clear guidelines - Identify key Phidisa personnel and identify a mentor for as many as possible (all operational teams) n Begin to develop the Phidisa Scholars Program (Discuss with Drs. Brodine, Emery and Neaton) - an opportunity for members of Phidisa to obtain advanced training and degrees (selection criteria / committee, pay-back obligation) n Recommend a process to identify conferences of relevance to Phidisa and to select individuals to attend those conferences (accepted abstract). Develop a budget for conference travel.

Specific Issues for Communications (03) n Develop communications strategy (includes the “communications” needs of the working groups) - September 1. n Some patients enrolled in Phidisa will die from HIV; for some the drugs will not work; for others there may be serious side effects. n Develop PD, identify person for Communications Coordinator position - strongly consider locating this SANDF or contract individual in the data/operations center. n Develop communications strategy (includes the “communications” needs of the working groups) - September 1. n Some patients enrolled in Phidisa will die from HIV; for some the drugs will not work; for others there may be serious side effects. n Develop PD, identify person for Communications Coordinator position - strongly consider locating this SANDF or contract individual in the data/operations center.

Specific Issues for Communications (04-1) n Develop strategy for improvement and maintenance of website (work with IT) n Evaluate role of newsletter(s) (work with site/clinical), posting schedule of conference calls and meeting minutes to the web and other strategies to improve internal and external communications. n Review and recommend changes for recruitment strategies (site development/clinical care) n Develop strategy for improvement and maintenance of website (work with IT) n Evaluate role of newsletter(s) (work with site/clinical), posting schedule of conference calls and meeting minutes to the web and other strategies to improve internal and external communications. n Review and recommend changes for recruitment strategies (site development/clinical care)

Specific Issues for Communications (04-2) n Begin process to create talking points, generic powerpoint presentations documenting the project and its accomplishments n Begin planning for the next annual meeting (work with EC to identify venue, chair and co- chairs) n Begin process to create talking points, generic powerpoint presentations documenting the project and its accomplishments n Begin planning for the next annual meeting (work with EC to identify venue, chair and co- chairs)

Specific Issues for External Advisory Committee Members n Use last year’s report as a template for this year’s report - include review of science agenda and operational issues n Feel free to sit in on the discussions of any of the operational teams n Use last year’s report as a template for this year’s report - include review of science agenda and operational issues n Feel free to sit in on the discussions of any of the operational teams

Specific Issues for Observers - those not specifically assigned n Feel free to sit in on the discussions of any of the operational teams n Identify yourself to the team n Respect the team process and realize that considerable work may have gone into arriving at a group consensus in any given area n Feel free to sit in on the discussions of any of the operational teams n Identify yourself to the team n Respect the team process and realize that considerable work may have gone into arriving at a group consensus in any given area

Specific Issues for the Executive Committee (03) n Identify a Director for the Operations Center (SANDF Clinical Research Center) n Develop better communications / tracking of information - Jackson Foundation n Monthly call with working group chairs and co-chairs to review progress n Identify a Director for the Operations Center (SANDF Clinical Research Center) n Develop better communications / tracking of information - Jackson Foundation n Monthly call with working group chairs and co-chairs to review progress

Specific Issues for the Executive Committee (03, con’t.) n Procurement of antiretrovirals n Develop an overall project plan including a budget and timeline n Identify strategies to show appreciation for work well done (travel to scientific meetings; etc.) n Procurement of antiretrovirals n Develop an overall project plan including a budget and timeline n Identify strategies to show appreciation for work well done (travel to scientific meetings; etc.)

Specific Issues for the Executive Committee (03, con’t.) n Clarification of the role of the Jackson Foundation n Day to day coordination and oversight of the program on behalf of the EC n Program facilitation n Develop a manual of operations for the administration of the program. n Travel policy n Approval of requests n Clarification of the role of the Jackson Foundation n Day to day coordination and oversight of the program on behalf of the EC n Program facilitation n Develop a manual of operations for the administration of the program. n Travel policy n Approval of requests

Specific Issues for Executive Committee (04) n Be available to answer questions and provide direction n May sit in on the discussions of any of the operational teams n Meet each evening to review the outcome of the day, share concerns, provide feedback to the teams and summary report on Friday n Be available to answer questions and provide direction n May sit in on the discussions of any of the operational teams n Meet each evening to review the outcome of the day, share concerns, provide feedback to the teams and summary report on Friday

Thoughts for the week…. n “Insanity: Doing the same thing over and over again and expecting different results.” Albert Einstein Princeton University n “…. my view is that people deserve to be given equal opportunity, but nobody deserves to be given success.” Mamphel A. Ramphele Seventh Vice Chancellor (1996) University of Capetown n “Insanity: Doing the same thing over and over again and expecting different results.” Albert Einstein Princeton University n “…. my view is that people deserve to be given equal opportunity, but nobody deserves to be given success.” Mamphel A. Ramphele Seventh Vice Chancellor (1996) University of Capetown